Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Prior treatment

• Anticipated renal transplant within 6 months
• Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft
• Previous enrolment in this study

Other illness

• History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF \<25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• Uncontrolled or poorly controlled diabetes
• Any active local or systemic infection
• Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
• Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
• Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit
  • Intra-operative exclusion criteria:
  • 1\. Unsuitable anatomy to implant the aXess graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)

Lab values

• Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds

Other

• Abnormal blood values that could influence patient recovery and or/ graft hemostasis
• Known heparin-induced thrombocytopenia
• Known or suspected central vein obstruction on the side of planned graft implantation
• Subject is participating in another study
• Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives

• Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy
• At least 18 years of age at screening
• Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft
• The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent
• The patient has been informed and agrees to pre- and post- procedure follow-up
• Life expectancy of at least 12 months